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Module
Topics
Days
1
Risk Based Strategy for the Development & Validation of
Analytical Methods with a QbD Approach -
for more
information or
click here to see a video click here
2
2
Qualification and Validation (IQ/OQ/PQ) of Laboratory
Instruments and Systems with a Risk Based Strategy for QS
Compliance  -
for more information click here
2
3
Cleaning Validation and Compliance Issues for the Pharma,
Biotech and Medical Device Industries
- for more information
click here
2
4
Good Distribution Practices (GDP) & Directives:
EU/WHO/Pedigree Law
2
5
Highlights of Process Analytical Technology (PAT) and FDA
Directives and QbD Era
2
6
The Qualified Person (QP) - Relevance, Role,
Responsibilities and Requirements in the Regulated
Industries/Quality Systems
2
7
Trends and Highlights of Global Compliance Issues - Risk
Management Approach (ICH, EMEA, WHO)
2
8
Study Director, QAU & Management: Roles and
Responsibilities in the GLPs (FDA/OECD)
2
9
Highlights of FDA/OECD Good Laboratory Practices - for
more information
click here
3
10
Recent Updates and Highlights of FDA and other cGMP
Regulations
2
11
Integration of ICH Directives, Risk Management & the GMP's
/ FDA's Science Based Policy
2
12
FDA Enforcement Actions, Deviations, & CAPA System
2
13
Methods Development, Validation Procedures and
Conformity Assessment in the Analytical Laboratory
1
14
Validation of Systems & Methods in the Analytical Laboratory
2
15
Perspectives of Stability Studies
3
16
Designing and Maintaining a Robust Quality System for
FDA/EPA/ISO Regulated (Food, Pharma, Specialty
Chemicals, Devices, Biotech...) Laboratories and
Organizations
1
Training Modules
In addition to the standardized courses we offer, VQI can
develop customized training to meet your organization's
requirements for either on-site or off-site venues.  Such
training activities inside companies help progressive
development at various professional levels.

If you would like a customized training course,
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